Identity
- Trade Name
- CB10-4 Ultrasound Probe(FDA) FDA UDI
- Generic Name
- Rectal ultrasound imaging system transducer FDA UDI
- Model / Reference
- 120-000452-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904087313 FDA UDI
- 510(k) Number
- K103583 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Rectal ultrasound imaging system transducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Rectal ultrasound imaging system transducer
CB10-4 Ultrasound Probe(FDA) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103583 also covers:
- 4CD4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 7L4A Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 7L5 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- B/W video printer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- B/W video printer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- C5-2 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-7 Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-7T Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DE10-3 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Footswitch (not USB port) — Shenzhen Mindray Bio-Medical Electronics Co.
- L11-4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- L12-4 Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 84517867-0650-4e26-bc9f-614d562b15d4 34 fields · synced May 30, 2026